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Research On Supervision And Management Of Adverse Reactions Of Drugs

Posted on:2017-10-06Degree:MasterType:Thesis
Country:ChinaCandidate:J J ChenFull Text:PDF
GTID:2336330512963123Subject:Economic Law
Abstract/Summary:PDF Full Text Request
In the development of human history,the use of drugs to resist pain can be traced back a long time ago.However,accompanied by a large number of drugs in the human body,the drug in the benefit of people at the same time,has also been found with a series of side effects,adverse reactions is one of them.Adverse drug reactions as an important impact on human health has been widely concerned about the health system around the world,countries have introduced various measures aimed at adverse drug reactions to effectively regulate the physical and mental health of citizens to provide protection.In recent years,many countries in the world,including China,frequent occurrence of large area of adverse drug reactions,including death or serious disability cases,the community is quite attention.Therefore,it is of great theoretical and practical significance to discuss the legal issues related to ADR regulation,and to look for problems in the supervision of ADR,and to conduct a comprehensive and systematic study.According to the former Ministry of Health promulgated the "adverse drug reaction reporting and monitoring management approach","the so-called adverse drug reactions,refers to the use of drugs in line with drug standards of drugs produced after the unrelated drug quality of the useless reaction." This definition in the " Article 63 of the Measures is to be clarified.On the one hand,the regulation of adverse drug reactions includes the regulation of administrative counterparts,ie,drug manufacturers,distributors and hospitals;on the other hand,the supervision of drug administration departments themselves,that is,the supervision of administrative authorities of adverse drug reactions.At present,there are four problems in the regulation of adverse drug reaction in our country,such as imperfection of legal system,imperfection of organization system,imperfect supervision method and non-standard supervision behavior.Analyzes the relevant provisions of the extraterritorial domain,and explores some good practices from it,and puts forward some corresponding perfect measures and suggestions for our reference,study and consideration of the reality of our country.Analysis of the relevant provisions of foreign countries,from which to explore some of the best practices for our reference,learning.Considering the reality of our country,around the problem,put forward four proposals.
Keywords/Search Tags:Drugs, Adverse reactions, Supervision
PDF Full Text Request
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